FDA - New Drug Application
(NDA) Process

Below is a basic outline of the process required by the Food and Drug Administration in order for a manufacturer to bring a new drug to the market.

The process is very lengthy and involves many details, however this is the basic framework. It is recommended to know about the NDA process to prepare for the ExCPT and PTCB exams.

New Drug Initial Development

· Pre-Clinical (animal) testing.

-Investigational New Drug Review (IND)
· Review of of Pre-clinical Trial results.
· Determination of safety to use on humans.
· Authorization to ship across state lines.

New Drug Clinical Trials

-Phase I
· Involves a small number of healthy volunteers (25-100).
· Safely tolerated dosages determined.
· Identification of major side-effects
· Emphasis on safety and maximum tolerated dosages.

-Phase II
· Involves many more volunteers (100-300).
· Emphasis on the drugs effect against what it's designed to treat.
· Effects compared with similar patients receiving different treatments.

-Phase III
· Involves a few more volunteers (300-3000).
· Emphasis on the drugs overall effect.
· Effects compared with patients unknowingly taking placebos
· Study of different populations and different dosages.
· Testing the drug in combination with other drugs.
· Final Phase before presenting to FDA for approval.

New Drug Post Approval Trials

-Phase IV
· Ongoing/Post approval trials.
· Health-care professionals to report any adverse findings.
· This phase lasts eternally, as long as the drug is on the market.

Time the process takes
This process can usually take
12-15 years. The time elapsed from a drugs discovery in a lab until it becomes available to market to the general public can be even longer. Keep in mind that a Patent only lasts 20 years from the time the application for patent was filed. After the patent runs out, competitors may seek approval to produce Generic drug equivalents. Also, It is estimated that less than half of new drugs approved for clinical trials ever make it to Phase III and less than 20% make it to market with FDA approval.

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